离子色谱法测定甘油磷酸钠注射液的成分及杂质

Determination of component and impurity in sodium glycerophospate injection by ion chromatography.

采用AS19离子色谱分析柱和KOH梯度淋洗，用抑制电导检测器对甘油磷酸钠注射液中主要成分以及氟离子、氯离子、磷酸根等杂质阴离子同时进行检测，被测物质甘油磷酸根的保留时间和峰面积的相对标准差分别小于0．339％和2．617％；被测物质的线性相关系数为0．9997～1．0000；加标回收率为90．5％～103％．采用该方法对实际样品的检测，结果令人满意．

A method was proposed for the simultaneous determination of component and impurity in sodium glycerophospate （GP） injection. Three species： fluoride, chloride and phosphate were analyzed by means of ion chromatography（IC） by using a gradient elution with KOH as mobile phase, using IonPac AS19 as separation column, and suppressed conductivity detector. Optimized analytical conditions were further validated for the results showed the reliability of the IC method. The relatives standard deviations （RSD） of the retention time and peak area of all species were less than 0. 339% and 2. 617%, respectively; the correlation coefficients for the target analytes ranged from 0. 999 7 to 1. 000 0. The spiked recoveries for the anions were 90. 5%-103.0%. This method was used in the determination of real sample and the result was satisfactory.